From: emmeratano@libero.it
Sent: Friday, March 09, 2001 7:04 PM
To: fdadockets@oc.fda.gov
to whom it may concern,
I am writing in support of a proposed rule that would provide public access to study design and safety information on all new or ongoing clinical trials involving either gene therapy or xenotransplantation.
both are potentially dangerous areas that the public should know about .This proposed rule only brings gene therapy or xenotransplantation in compliance with the same types of information already released to the public by other governement agencies .
Because of the grave public health risks ,disclosure should include additional information such as names of physicians conducting the trials and names of partecipating medical centers .All information should be made public except trade secrets and patient identification. The FDA must assume the sole responsability for summarizing and distributing information submitted by the research sponsors ,rather than leave it to the sponsors'discretion.
I strongly believe that because of the public health risks,legal and ethical iusses ,enormous cost ,serious animal welfare concerns,and the failure to adequately assess other alternatives ,all xenotransplantation clinical trials should stop funding xenotransplantation research.
Sincerely,
Maria Ratano ,Lecce ITALY.